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Aortic Aneurysm, Abdominal clinical trials

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NCT ID: NCT06451315 Recruiting - Clinical trials for Abdominal Aortic Aneurysm

REGISTRY on the Implementation of Artificial Intelligence in the Automatic Analysis of Vascular Network Segmentation

IAVASC
Start date: January 30, 2024
Phase:
Study type: Observational

The team hypothesizes that fully automatic analysis of AAA could provide increased performance (decreased duration of segmentation with increased reproducibility and decreased inter and intraobserver variability) to detect aortic aneurysmal sac enlargement (volumes and diameters) and predict the risk of complications during the procedure and during follow-up (MAE, MACE, MALE, Stroke) compared to standard methods of measurement relying on approximate maximum sac diameter.

NCT ID: NCT06365138 Recruiting - Aortic Aneurysm Clinical Trials

Analysis of Individual Activity at the Time of Aortic Rupture in Patients With Abdominal Aortic Aneurysms

Start date: January 1, 2024
Phase:
Study type: Observational

It is currently unclear what activities aneurysms are involved in at the time of rupture. The aim of the study is to determine the activity performed at the time of aneurysm rupture.

NCT ID: NCT06286540 Recruiting - Clinical trials for Aorta Thoracic; Aneurysm

Evaluation of the Efficacy and Safety of Surgical Device "Lymphoblock" for Prevention of Lymphorrhea in Patients With Thoracoabdominal Aorta Repair.

Start date: February 22, 2023
Phase: N/A
Study type: Interventional

Randomized, double-blind, placebo-controlled study will determine the clinical efficacy and safety of Lymphoblock in the prevention of postoperative retroperitoneal chylo-/lymphorrhoea in patients with open surgical treatment of the thoracoabdominal aorta. It is planned to recruit 138 clinical observations. Efficacy will be evaluated based on clinical and laboratory data.

NCT ID: NCT06250998 Recruiting - Clinical trials for AAA - Abdominal Aortic Aneurysm

Prediction of Abdominal Aortic Aneurysm Shrinkage After Stent-placement With Artificial Intelligence

ARTinEVAR
Start date: April 3, 2024
Phase:
Study type: Observational

The goal of this observational study is to find out what factors contribute to a good treatment outcome in patients who have received a stent for their dilation of the main abdominal artery (abdominal aortic aneurysm or AAA). The primary goal of this study is to build a prediction model for abdominal aortic aneurysm shrinkage one year after the treatment.

NCT ID: NCT06244732 Recruiting - Postoperative Pain Clinical Trials

Pain Control After Aortic EndoaneurYsmEctomy (POPEYE)

POPEYE
Start date: February 19, 2024
Phase: N/A
Study type: Interventional

Open abdominal aortic aneurysm repair (OR-AAA) is an operation associated with high morbidity, and has 30-day mortality rates of between 4 and 14%. Post-operative pain management represents a primary anesthetic focus. A better analgesia, in addition to being desirable for the patient, can potentially reduce complications associated with postoperative pain and ensure faster functional recovery. The modern concept of multimodal analgesia involves the association of multiple drugs and/or analgesic techniques to maximize the quality of analgesia and reduce the side effects of the individual methods. In this context, the addition of epidural analgesia (EA) to the intravenous administration of "traditional" analgesic drugs has assumed the role of gold standard in many surgeries, including OR-AAA. Over time, EA has proven to be a better analgesic technique than the use of intravenous opioids alone, however there is much uncertainty regarding its ability to reduce complications, morbidity and mortality of patients. For some time, efforts to research effective, less invasive and safe anesthetic alternatives, have been directed towards the development of multimodal analgesia protocols with the aim of reducing complications and ensuring faster recovery. New approaches to post-operative pain management are emerging, including rectus sheat block (RSB). Currently there is no evidence regarding the effectiveness of RSB in pain control after OR-AAA. In this context, the study aims to compare two different post-operative pain management protocols, with the aim of verifying whether the use of RSB can guarantee a non-inferior level of analgesia with reduction of complications compared to AE.

NCT ID: NCT06218875 Recruiting - Clinical trials for AAA - Abdominal Aortic Aneurysm

Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis

Start date: May 7, 2024
Phase:
Study type: Observational [Patient Registry]

A prospective, observational post-market registry collecting outcomes through a 10-year post procedure follow-up for patients treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC Device) or the GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE Device) as a part of routine clinical practice.

NCT ID: NCT06206369 Recruiting - Clinical trials for Peripheral Arterial Disease

Developing Trustworthy Artificial Intelligence (AI)-Driven Tools to Predict Vascular Disease Risk and Progression

VASCULAIDRETRO
Start date: October 31, 2023
Phase:
Study type: Observational

The VASCULAID-RETRO study, within the broader VASCULAID project, aims to create artificial intelligence (AI) algorithms that can predict cardiovascular events and the progression of abdominal aortic aneurysm (AAA) and peripheral arterial disease (PAD). The study plans to gather and analyze data from at least 5000 AAA and 6000 PAD patients, combining existing cohorts and retrospectively collected data. During this project, AI tools will be developed to perform automatic anatomical segmentation and analyses on multimodal imaging. AI prediction algorithms will be developed based on multisource data (imaging, medical history, -omics).

NCT ID: NCT06029660 Recruiting - Clinical trials for Aortic Aneurysm, Abdominal

AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion

Start date: April 5, 2024
Phase: N/A
Study type: Interventional

To determine the safety and effectiveness of IMPEDE-FX RapidFill to increase the percentage of subjects with shrinkage of the abdominal aortic aneurysm sac when used as an adjunct to on-label endovascular aneurysm repair (EVAR) stent graft treatment in trial subjects considered candidates for elective EVAR.

NCT ID: NCT06008613 Recruiting - Clinical trials for Abdominal Aortic Aneurysm

3D Holographic Guidance, Navigation, and Control for Endovascular Aortic Repair

3D-GN&C
Start date: October 18, 2023
Phase: N/A
Study type: Interventional

This is an Early Feasibility Study to evaluate the usability, safety and functionality of 3D holographic guidance, navigation, and control (3D-GNC) as an adjunct to and confirmed by fluoroscopic imaging to be used with Cook Zenith Flex AAA Endovascular Graft.

NCT ID: NCT06001918 Recruiting - Clinical trials for Abdominal Aortic Aneurysm

Nectero EAST System Clinical Study

stAAAble
Start date: October 25, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this randomized clinical trial is to treat patients with small to mid-sized abdominal aortic aneurysms (AAA), maximum diameter of 3.5 cm to 5.0 cm, using a locally delivered, single-dose endovascular treatment. The main question the study aims to answer is to demonstrate efficacy of the product for stabilization of these small to mid-sized AAA.The study will compare the treatment group to the typical standard of care for these patients, surveillance. All subjects will be followed at designated intervals at 30/60 days, 6, 12, 18 and 24 months with continued follow-up annually for up to 5 years.